Cocaine/Crack and Reduction of Compulsion With Biperiden
Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence; Crack Dependence
Intervention: Biperiden (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Federal University of São Paulo Overall contact:
José C.F. Galduróz, MD/PhD, Phone: +5511-2149-0168, Email: galduroz@psicobio.epm.br
Summary
Cocaine consumption affects around 13. 4 mi people or 0. 3% of the world population between 15
and 64 years old. The drug dependence has been described by many authors as a dysfunction of
the brain reward system. Considering the effects of the cholinergic system on the drug
reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on
cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a
cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug
dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50
years old will be study. This is a double-blind controlled and randomized placebo study. All
the patients will be treated with brief intervention therapy (BIT), and half of them will
receive biperiden (6mg/day) while the other half will receive placebo. The treatment
efficacy will be evaluated through the comparison between the values obtained on the
following measures before and after the treatment: Craving scale of Minnesota and
Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite
(benzoylecgonine) on urine.
Clinical Details
Official title: Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Compulsion score
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)
Exclusion Criteria:
- Being under treatment with psychoactive drugs
- Have been diagnosed for other Psychiatric Disorders
- Have dependence diagnosis for other drugs, except for tabacco
Locations and Contacts
José C.F. Galduróz, MD/PhD, Phone: +5511-2149-0168, Email: galduroz@psicobio.epm.br
UDED - Drug Dependence Unit, São Paulo 04024-003, Brazil; Recruiting
Maria Lucia O.S. Formigoni, PhD, Phone: +5511-5549-2500, Email: mlformig@psicobio.epm.br
Additional Information
Starting date: May 2011
Last updated: June 21, 2011
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